Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212614
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric secretion on the volume as well as the acidity of gastric secretion by high dose proton pump inhibitors in GERD patients and healthy controls. Twelve participants in each group will be studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI technique developed in Zurich will assess the volume of gastric secretion following the ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will assess the link between volume and intragastric distribution of gastric secretion on reflux events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Healthy Volunteers Procedure: MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study for Measurement of Gastric Secretion by Magnetic Resonance Imaging (MRI) Under Inhibition of Gastric Secretion by Proton Pump Inhibitors in Healthy Subjects and Patients With Reflux Disease
Study Start Date : October 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Intervention Details:
    Procedure: MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring
    MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring

Primary Outcome Measures :
  1. To assess the volume of gastric secretion in GERD patients and healthy volunteers with and without acid suppression. [ Time Frame: October 2010 - October 2012 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria: - Healthy volunteers must have less than one episode of reflux or dyspeptic symptoms per month of no more than mild severity in the last 3 months

- Reflux patients (GERD) must have chronic symptoms (>8 weeks) suggestive for GERD (definition and questionnaire see Appendix page 30). In addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). If in addition a pH-study has been performed the acid exposure must be > 4.2% / 24h.

Exclusion criteria: - Age under 18 or above 65

  • Pathologic underweight or overweight (BMI < 18 or > 30 kg/m2)
  • Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)
  • Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse
  • Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs
  • Positive Helicobacter pylori status on 13C-Urea breath test
  • Presence of metallic implants, devices or metallic foreign bodies
  • Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
  • Female volunteers without adequate contraception for the duration of the study
  • Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212614

University of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Principal Investigator: Werner Schwizer, Professor MD University Hospital Zurich, Gastroenterology and Hepatology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Zurich Identifier: NCT01212614     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2010-0293
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action